Equity Research Immunovia: Second clinical validation of next-generation test

On 19 March, Immunovia announced positive top-line results from the VERIFI study, the second clinical study to test the accuracy of the next-generation test. So far, limited data has been released; however, the study met its primary endpoint with a sensitivity of 77 per cent.

Promising first data from VERIFI study

On Wednesday the 19 March, Immunovia released the results from the second clinical validation study of its next-generation pancreatic cancer test. The study met its primary endpoint, with a successful detection of stage I and II pancreatic cancer in 77% of samples. In total, the study was conducted using 385 blood samples from six pancreatic cancer centers in the USA. Of the 385 samples, 115 samples were from patients diagnosed with stage I and stage II pancreatic ductal adenocarcinoma (PDAC), the most common variation of pancreatic cancer. The 270 control samples came from patients who were classified as high-risk individuals, meaning that they had a family history of pancreatic cancer, harmful genetic mutations (e.g., BRCA2), pancreatic cysts, or a combination of all the above. Compared to the CLARITI study, pancreatic cysts were a new variable added.

The study was smaller than the CLARITI study, which included over 1,000 patient samples as compared to the 385 samples used for the VERIFI study. Furthermore, at this point in time, only the sensitivity of the test has been revealed. That is to say, so far, we only know how many of the 115 samples were accurately identified as stage I or II PDAC, but not how many of the samples from individuals without pancreatic cancer were accurately identified as negative. However, Immunovia states that further results from the study will be shared in upcoming scientific meetings and publications. Furthermore, worth pointing out is that although the total number of samples in VERIFI study was smaller than in the CLARITI study, the number of samples from patients with PDAC was, relatively speaking, a higher proportion of the total number of samples. Namely, samples from patients with diagnosed stage I or II PDAC was 29.8% of the total, as compared to the 18.9% of the total in the CLARITI study. Also, it is as of yet uncertain as to what impact the inclusion of patients with pancreatic cysts had on the data.

Taken together, Carlsquare Equity Research is pleased to see a positive outcome from a second clinical validation study. We expect that the results from this study will help in attaining an attractive level of reimbursement later down the line. Immunovia is seeking to launch the next-generation test in Q3 2025, although initially as a Laboratory-Developed Test (LDT), meaning reimbursement will most likely come at a later stage. We expect the market to react positively to the result.

We expect to publish a research update when more clinical data is published from the CLARITI and VERIFI studies.

Read our initiation of coverage here.

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